A New Chemical Entity (NCE) minus 1 filing, also known as a paragraph IV filing, is a type of application submitted to the U.S. Food and Drug Administration (FDA) for a new drug that represents a slight modification of an existing approved drug. The term "minus 1" indicates that the NCE is only one small…
A New Chemical Entity (NCE) refers to the discovery of new compound in the pharmaceutical industry. This compound has a novel structure, possibly a new chemical class that the innovator has discovered. NCE also implies that such a compound is entirely new and has never been approved for medical use by any regulatory authority worldwide.…
A tablet is a pharmaceutical oral dosage form containing medicinal substances, with or without additional ingredients. According to the Indian Pharmacopoeia, pharmaceutical tablets are solid, flat, or biconvex units created by compressing drugs or a mixture of drugs, with or without diluents. These tablets come in various shapes, sizes, colors and weights, which depend on…
An expectorant is a type of cough medicine. This class of medication helps in soothing the sore throat. Few expectorants contain agents that help to loose and expel the mucus from the respiratory system. It works by boosting saliva production and thinning mucus (phlegm), facilitating easier coughing and clearing airways. Expectorants are frequently used to…
There are different types of oral medicines. They are available as tablets, capsules, chewable tablets, and orally disintegrating tablets, which can be swallowed whole or dissolved in the mouth. Medications can also be in liquid forms, such as drops, syrups, or solutions. They are also available as powders and granules to be mixed with water…
In this day and age with the ever-evolving medical sciences, new discoveries and therapeutic interventions are reported almost every day. The injection has been an indispensable part of medicine practice for several years. With that, injections are a necessity for serving life saving treatments through administration directly into the blood, making the medicinal component available…
A vaccine is a suspension of killed, weakened or fragmented microorganisms, toxins or any other biological preparation consisting of antibodies, lymphocytes, or mRNA, administered to offer protection from contagious infections. The primary components of vaccines include:
Antigens: Antigens are the primary active components in vaccines. They can consist of parts of the virus or bacteria…
Capsules are cylindrical-shaped oral dosage forms containing medicine and manufactured for ease of swallowing and masking the taste of the medicines. The pharmaceutical capsules are a preferred choice when, due to technical issues such as formulation and manufacturing limitations tablets can not be manufactured and physiological reasons to protect the medicament from the direct effect…
Medicinal products need an appropriate storage facility as they are unique for maintaining their quality in terms of stability and potency. Specific conditions of temperature are required by certain medications in the range of (2-8) ℃ whereas few of them need storage below 0℃. Medicinal products that require such conditions of temperature are known as…
Pharmaceutical products are special commodities and require special storage conditions and specific distribution logistics. In pharmaceutical depots no other products apart from medicines can be stored together. The pharmaceutical warehouse needs to possess specific design, area demarcations and entry-exit procedures. It needs to obtain a drug storage and distribution license from the authorized agencies. Thus,…